1. Field of the Invention
This invention relates to a nutritionally fortified pharmaceutical composition for the administration to patients in a hypermetabolic state such as those suffering from a substantial burn, trauma, major surgery and the like, and more particularly to a composition for enteral administration to patients who have encountered a substantial burn injury to the skin or other areas from contact with heat, radiation, electricity or chemicals.
2. Disclosure Statement
Patients suffering from a traumatic injury such as a substantial burn (involving an area greater than about 45 percent of the surface area of a human) become hypermetabolic and are highly susceptible to the development of malnutrition and infection. In 1970 of the patients who survived more than one week, roughly 75 percent died of infectious complications. While substantial improvement has taken place since then, what is needed is an improved nutritionally fortified pharmaceutical composition which will aid the traumatically injured patient manifesting or about to manifest a hypermetabolic state associated with a traumatic injury by attenuating the hypermetabolic state thereby lessening malnutrition and infection associated with a traumatic injury. In patients where the GI tract is still functioning but who are unable to orally take in adequate amounts of nutrients, enteral nutrition is the preferred route of nutritional administration relative the parenteral route.
Generally speaking, enteral nutrition products may be administered orally or by tube feeding routes. The nasogastric, nasoduodenal and nasojejunol routes are nonsurgical. Whereas, the jejunostomy, gastrostomy and esophagostomy are surgically inserted. Enteral nutrition products may also be administered by mouth where the patient is able. The nasoduodenal and nasojejunal are generally used in an unconscious patient and those with an impaired gag reflex in order to minimize the likelihood of aspiration.
Numerous enteral formulations are utilized in patients with a hypermetabolic state as effected by burns, trauma, major surgery and in those patients with malnutrition syndromes, neoplasms, chronic illnesses and in disorders resulting from prolonged periods of reduced oral intake resulting from cerebral vascular accidents or a comatose state.
ISOCAL is an enteral formulation by Mead Johnson which utilizes casein and soy for its protein source, glucose oligosacchrides for its carbohydrate source and soy oil and medium chain triglycerides (MCT) oil for its lipid source. The composition includes about 19 grams linoleic acid per liter.
OSMOLITE is manufactured by Ross and utilizes as its protein source casein and soy, corn starch for its carbohydrate source and fifty percent MCT oil, forty percent corn oil and ten percent soy oil for its lipid source. The composition includes about 11.5 grams linoleic acid per liter.
ENSURE is manufactured by Ross and utilizes casein and soy for protein source, corn starch and sucrose for a carbohydrate source and corn oil for a lipid source. The composition includes about 19.6 grams linoleic acid per liter.
SUSTACAL manufactured by Mead Johnson utilizes casein and soy for its protein source, corn syrup and sucrose for its carbohydrate source and soy oil for its lipid source. The composition includes about 6.8 grams linoleic acid per liter.
ENSURE PLUS manufactured by Ross is a high protein composition using soy and casein for its protein source, corn starch and glucose for its carbohydrate source and corn oil for its lipid source. The composition includes about 27 grams linoleic acid per liter.
MAGNACAL manufactured by Chesebrough Ponds is a high density composition with 2.0 calories/ml. MAGNACAL utilizes casein for its protein source, corn syrup for its carbohydrate source and soy oil for its lipid source. The composition includes about 59 grams linoleic acid per liter.
TRAUMACAL manufactured by Mead Johnson utilizes casein for its protein source, corn syrup and sucrose for its carbohydrate source and 70 percent soy bean oil and 30 percent MCT oil for its lipid source. The composition includes about 27 grams linoleic acid per liter.
PRECISION ISOTEIN HN is manufactured by Sandoz and utilizes lactalbumin for its protein source, maltodextrin for its carbohydrate source and soy oil and MCT oil for its lipid source. The composition includes about 3.4 grams linoleic acid per liter.
The above enteral compositions fail to provide omega-3 fatty acids including eicosapentaenoic acid or a nutritionally fortified pharmaceutical composition containing omega-3 fatty acids of fish oil including eicosapentaenoic acid for the reduction or attenuation of hypermetabolic states associated with traumatic injuries such as a burn injury, trauma and major surgery and especially substantial burn injuries.
Therefore, it is an object of this invention to provide a nutritionally fortified pharmaceutical composition and method to aid in the treatment of a traumatic injury with an impaired immune response and an associated hypermetabolic state especially where the hypermetabolic state and immunologic depression are the result of a traumatic injury such as a substantial burn injury.
Another object of this invention is to provide a nutritionally fortified pharmaceutical composition which provides omega-3 fatty acids including eicosapentaenoic acid in an amount sufficient to reduce the hypermetabolic resting metabolic state associated with those suffering from a traumatic injury and limits the amount of linoleic acid in the composition to the amount needed for preventing essential fatty acid deficiency.
Another object of this invention is to provide a nutritionally fortified pharmaceutical composition for administration to one suffering from a traumatic injury which decreases the amount of arachidonic acid pathway metabolites formed in a traumatically injured patient thereby enhancing healing of a traumatic injury in the patient in need of such treatment.
Another object of this invention is to provide a method of treating a patient suffering from a traumatic injury, such as a burn injury, by providing to one in need of such treatment omega-3 fatty acids including eicosapentaenoic acid in an amount sufficient to attenuate a hypermetabolic response associated with the traumatic injury and limiting the amount of linoleic acid to the amount needed for preventing essential fatty acid deficiency to enhance the healing rate of the burn injury.
Another object of this invention is to provide a nutritionally fortified pharmaceutical composition which provides omega-3 fatty acids including eicosapentaenoic acid which enhances the healing rate of a traumatic injury.
Another object of this invention is to provide a nutritionally fortified pharmaceutical composition and method which results in less weight loss, in better skeletal muscle mass maintenance, in a lower resting metabolic expenditure, better opsonic indices, higher splenic weight, lower adrenal weight, higher serum transferrin, lower serum C3 levels and in a better cell mediated immune response for use in a patient with a traumatic injury and its associated hypermetabolic response and immunologic depression.
Another object of this invention to provide a composition which attenuates a hypermetabolic response in a patient in need of such treatment.
The foregoing has outlined some of the more pertinent objects of the present invention. These objects should be construed to be merely illustrative of some of the more pertinent features and applications of the invention. Many other beneficial results can be obtained by applying the disclosed invention is a different manner or modifying the invention within the scope of the disclosure. Accordingly, other objects and a fuller understanding of the invention may be had by referring to the summary of the invention and the detailed description describing the preferred embodiment in addition to the scope of the invention defined by the claims taken in conjunction with the accompanying formulations and figures.